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| ID | Type | Description | Link |
|---|---|---|---|
| 965231 | Other Grant/Funding Number | European Union's Horizon 2020 research and innovation programme |
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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
| Centre for Research and Technology Hellas | OTHER |
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This is a single center prospective observational cohort study that aims to:
The patients who follow the inclusion criteria of the study will be asked to complete:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CIPN group | Breast cancer patients that developed strong CIPN symptomatology at post-treatment evaluation (4 weeks after the end of therapy) |
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| No-CIPN group | Breast cancer patients that developed mild-to-no CIPN symptomatology at post-treatment evaluation (4 weeks after the end of therapy) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Garmin smartwatch | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation of significant deterioration in neurophysiological parameters including alterations in morphology of small fibers or reduced IENFD (Intraepidermal Nerve Fiber Density) on first follow up visit and development of CIPN | by performing detailed clinical neurophysiological examination and skin biopsies (where IENFD will be quantified) in different timepoints as described in the study protocol | 1 year |
| Correlation of abnormal laboratory tests in baseline assessment with development/severity of CIPN | 1 year | |
| Correlation of parameters of NCS, temperature thresholds, and IENFD at baseline screening with development and severity of CIPN | 1 year | |
| Biochemical and metabolic abnormalities prior to paclitaxel treatment and their association with the development of CIPN | by performing blood tests, genotyping and skin biopsies | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Calculate and compare the false negative and false positive rate of CIPN in every used method during follow up | 1 year | |
| Association of altered scoring in different questionnaires (Fact/GOG-Ntx, SFN-SIQ) and different examinations (UENS) with the presence and severity of CIPN |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be identified as potential candidates and consecutively recruited from the oncology clinic at Karolinska University Hospital in Solna. Eligible candidates are patients who have been primarily operated for early non-metastatic breast cancer and are recommended by the multidisciplinary conference to receive adjuvant chemotherapy containing paclitaxel.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Theodoros Foukakis, MD,PhD | Contact | 0736896713 | theodoros.foukakis@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Theodoros Foukakis, MD, PhD | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Recruiting | Solna | Stockholm County | 171 76 | Sweden |
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| Label | URL |
|---|---|
| REBECCA stands for REsearch on BrEast Cancer induced chronic conditions supported by Causal Analysis of multi-source data and aims to tap into the potential of Real-World Data to support clinical research and to improve existing clinical work | View source |
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Blood and skin samples will be taken in different timepoints of the study as described in the protocol. Specifically, from each patient at least 10 ml of blood will be collected and 2 skin samples (3 mm wide, 2-3 mm deep)
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| REBECCA Mobile application | Other |
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| REBECCA PC plug-in | Other |
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| 1 year |
| Evaluation of whether specific genotypes of breast cancer and higher or lower levels of different proteins are related with higher incidence rate and severity of CIPN | by extracting DNA from blood samples and performing subsequent genotyping using SNP-array and GWAS. Also, by using proteomics analysis in blood samples and measure plasma levels of different proteins. | 2 years |
| Study any correspondence between deterioration of QoL indicated by REBECCA monitoring system and standardized patient self-reported measures with diagnosed CIPN after implementation of different methods during follow up | 2 years |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011115 | Polyneuropathies |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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